Trial · NCT01493531

Combining Lesinurad With Allopurinol in Inadequate Responders

NCT01493531, Phase 3, Completed, Ardea Biosciences, Inc.; results first posted 2016-05-26

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Combining Lesinurad With Allopurinol in Inadequate Responders. Trials, record NCT01493531. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01493531

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combining Lesinurad With Allopurinol in Inadequate Responders
NCT number: NCT01493531
Status: Completed
Phases: Phase 3
Enrollment: 610 participants, actual
Lead sponsor: Ardea Biosciences, Inc.
Conditions: Gout
Interventions: Lesinurad, Lesinurad, Placebo, Allopurinol
First posted: 2011-12-16
Last updated: 2016-05-26
Other registries' IDs: eudract:2011-003767-29
Results first posted: 2016-05-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.	6 months	Proportion of subjects with an sUA level that is \< 6.0 mg/dL by Month 6.
Secondary	Gout Flares	12 Months	Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.
Secondary	Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12	12 months	Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.	6 months	Intent-to-Treat Population	Proportion of Subjects	NUMBER
SECONDARY	Gout Flares	12 Months		Gout Flares	MEAN
SECONDARY	Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12	12 months		Proportion of Subjects	NUMBER

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.	Lesinurad 200 mg + Allopurinol	0.554		Proportion of Subjects
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.	Lesinurad 400 mg + Allopurinol	0.665		Proportion of Subjects
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.	Placebo + Allopurinol	0.233		Proportion of Subjects
Gout Flares	Lesinurad 200 mg + Allopurinol	0.7	Standard Deviation 1.4	Gout Flares
Gout Flares	Lesinurad 400 mg + Allopurinol	0.8	Standard Deviation 1.7	Gout Flares
Gout Flares	Placebo + Allopurinol	0.9	Standard Deviation 1.8	Gout Flares
Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12	Lesinurad 200 mg + Allopurinol	0.314		Proportion of Subjects
Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12	Lesinurad 400 mg + Allopurinol	0.276		Proportion of Subjects
Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12	Placebo + Allopurinol	0.333		Proportion of Subjects

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lesinurad 200 mg + Allopurinol	204
Overall Study	STARTED	Lesinurad 400 mg + Allopurinol	200
Overall Study	STARTED	Placebo + Allopurinol	206
Overall Study	COMPLETED	Lesinurad 200 mg + Allopurinol	163
Overall Study	COMPLETED	Lesinurad 400 mg + Allopurinol	150
Overall Study	COMPLETED	Placebo + Allopurinol	158
Overall Study	NOT COMPLETED	Lesinurad 200 mg + Allopurinol	41
Overall Study	NOT COMPLETED	Lesinurad 400 mg + Allopurinol	50
Overall Study	NOT COMPLETED	Placebo + Allopurinol	48

Source ClinicalTrials.gov

Adverse events153

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Upper respiratory tract infection	Infections and infestations	Lesinurad 200 mg + Allopurinol	14	204	16
other	Upper respiratory tract infection	Infections and infestations	Lesinurad 400 mg + Allopurinol	30	200	39
other	Upper respiratory tract infection	Infections and infestations	Placebo + Allopurinol	21	206	23
other	Influenza	Infections and infestations	Lesinurad 200 mg + Allopurinol	14	204	17
other	Influenza	Infections and infestations	Lesinurad 400 mg + Allopurinol	8	200	9
other	Influenza	Infections and infestations	Placebo + Allopurinol	4	206	4
other	Bronchitis	Infections and infestations	Lesinurad 200 mg + Allopurinol	9	204	9
other	Bronchitis	Infections and infestations	Lesinurad 400 mg + Allopurinol	4	200	4
other	Bronchitis	Infections and infestations	Placebo + Allopurinol	4	206	5
other	Headache	Nervous system disorders	Lesinurad 200 mg + Allopurinol	10	204	11

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lesinurad 200 mg + Allopurinol
Total, all-cause mortality	Lesinurad 400 mg + Allopurinol
Total, all-cause mortality	Placebo + Allopurinol
Total, other adverse events	Lesinurad 200 mg + Allopurinol	85	204
Total, other adverse events	Lesinurad 400 mg + Allopurinol	82	200
Total, other adverse events	Placebo + Allopurinol	60	206
Total, serious adverse events	Lesinurad 200 mg + Allopurinol	9	204
Total, serious adverse events	Lesinurad 400 mg + Allopurinol	19	200
Total, serious adverse events	Placebo + Allopurinol	8	206

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27821644	DERIVED	PubMed
35835008	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01493531

GET https://conductscience.org/api/trials/v1/NCT01493531/events?page=2

API reference For AI assistants